Accuracy of package inserts of SARS-CoV-2 rapid antigen tests: a secondary analysis of manufacturer versus systematic review data

Author:

Bigio Jacob,MacLean Emily L-H,Das Rishav,Sulis Giorgia,Kohli Mikashmi,Berhane Sarah,Dinnes Jacqueline,Deeks Jonathan J,Brümmer Lukas E,Denkinger Claudia M,Pai Madhukar

Publisher

Elsevier BV

Subject

Virology,Infectious Diseases,Microbiology (medical),Microbiology

Reference16 articles.

1. Antigen-detection in the diagnosis of SARS-CoV-2 infection: interim guidance,2021

2. Use of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing: interim guidance,2022

3. Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection;Dinnes;Cochrane Database Systematic Rev,2022

4. Performance evaluation of in vitro diagnostic medical devices: methodology and differences compared to studies on other medical devices;Grifa;Microchem J,2018

5. Technical guidance series for WHO prequalification – diagnostic assessment. Designing instructions for use for in vitro diagnostic medical devices,2017

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